- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07373314
Modified vs. Conventional Laparoscopic TAPP for Inguinal Hernia
January 19, 2026 updated by: Taseen Imran, University of Health Sciences Lahore
A Randomized Controlled Trial Comparing Modified Tumescent vs. Conventional Laparoscopic TAPP for Inguinal Hernia Repair
This study aims to compare the outcomes of two laparoscopic techniques for repairing inguinal hernias: the modified tumescent technique (MT-TAPP) and the conventional laparoscopic transabdominal preperitoneal technique (CL-TAPP).
The primary goal is to determine which technique provides better outcomes in terms of operative time, ease of pre-peritoneal space dissection, postoperative pain, and the formation of seromas.
The study will involve 60 patients diagnosed with unilateral inguinal hernias, randomly assigned to either group.
Participants in Group A will undergo the MT-TAPP procedure, which involves pre-peritoneal infiltration of a local anesthetic solution to improve dissection and reduce pain.
Group B will undergo the standard CL-TAPP procedure.
Data will be collected on various outcome measures and analyzed to identify which technique leads to quicker recovery, less postoperative pain, and fewer complications.
The results of this study will help guide surgical decisions and improve patient outcomes in inguinal hernia repair.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dr. Taseen Imran
- Phone Number: 923045079008
- Email: taseenimran5@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age: 18 to 50 years.
- Gender: Both male and female participants.
- Condition: Diagnosed with unilateral inguinal hernia (as per operational definition).
- Health Status: ASA I-III (American Society of Anesthesiologists physical status classification), indicating that the patient is fit for surgery.
- Consent: Participants must be able to provide informed consent to participate in the study.
Exclusion Criteria:
- Femoral Hernias.
- Incarcerated or Strangulated Hernia.
- Recurrent Hernias (as per medical record).
- Serious Systemic Diseases:
- Conditions such as heart failure or coagulation problems (e.g., PT > 15 sec).
- ASA III-V classification, indicating a higher risk for surgery.
- Pregnancy (if applicable).
- Allergy to Anesthesia or the substances used in the tumescent solution (lidocaine, epinephrine, saline).
- Uncontrolled Diabetes or other medical conditions that might interfere with the healing process.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modified Tumescent Laparoscopic TAPP (MT-TAPP)
|
In this intervention, participants will undergo laparoscopic inguinal hernia repair using the modified tumescent technique.
This technique involves pre-peritoneal infiltration of a solution containing lidocaine, epinephrine, and saline.
The tumescent solution is injected into the peritoneum to create a "tumescent" effect, making the tissues easier to dissect and reducing bleeding.
This approach aims to improve surgical visibility, reduce operative time, minimize postoperative pain, and shorten the learning curve for less experienced surgeons.
The rest of the procedure follows the standard laparoscopic TAPP repair, with mesh placement and peritoneal closure.
|
|
Active Comparator: Conventional Laparoscopic TAPP (CL-TAPP)
|
In this intervention, participants will undergo the conventional laparoscopic transabdominal preperitoneal (TAPP) hernia repair.
This standard technique involves placing three ports to access the inguinal region, followed by dissection of the pre-peritoneal space and placement of a mesh to repair the hernia.
The conventional method does not use tumescent infiltration and relies solely on the surgeon's skill to navigate the anatomical structures.
This approach is well-established and commonly used in inguinal hernia repairs, but it may be associated with longer operative times and more postoperative pain compared to the modified technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Score
Time Frame: Recorded 24 hours post-surgery.
|
A score of 0 represents no pain, while a score of 10 represents the worst pain.
|
Recorded 24 hours post-surgery.
|
|
Seroma Formation:
Time Frame: Presence or absence of seroma, assessed during the 7-day postoperative follow-up.
|
Presence or absence of seroma, assessed during the 7-day postoperative follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 10, 2026
Primary Completion (Estimated)
August 15, 2026
Study Completion (Estimated)
August 30, 2026
Study Registration Dates
First Submitted
January 13, 2026
First Submitted That Met QC Criteria
January 19, 2026
First Posted (Actual)
January 28, 2026
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Exp132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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